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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Nebulized amikacin for VA-ECMO–associated pneumonia in adults

Official title: " Study of the Benefit of Nebulized Amikacin in the Treatment of Gram-negative Bacillus Pneumonia Acquired During Mechanical Ventilation in Patients Receiving Extracorporeal Membrane Veno-arterial Oxygenation "

Run by Assistance Publique - Hôpitaux de Paris · NCT06602557 · Data updated 2026-11-12

We’re testing whether giving amikacin as a nebulized inhaled medicine helps clear gram-negative pneumonia in adults on VA-ECMO who are also on mechanical ventilation.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment26 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Paris)
StatusRecruiting
StartedAugust 10, 2026
Main results expectedAugust 10, 2028
Study endsFebruary 10, 2029
Registry record updatedAugust 13, 2026
Trial IDNCT06602557 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) on VA-ECMO for at least 24 hours with invasive ventilation and a clinical/microbiological diagnosis of gram-negative VAP.

Probably not a fit

Patients without gram-negative pneumonia, those with non-ECMO-related pneumonia, or those unable to receive nebulized therapy may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study targets adults on VA-ECMO with suspected or confirmed ventilator-associated pneumonia due to gram-negative bacteria. Participants receive nebulized amikacin in addition to standard care, aiming to improve pulmonary antibiotic penetration where ECMO may limit lung blood flow. The trial compares outcomes with the usual antibiotic regimen to see if bacterial clearance and clinical success improve. The design considers pharmacokinetics and safety of inhaled amikacin in a critically ill population. Enrollment is at a major Paris hospital under a public healthcare sponsor.

Why it matters

Potential benefit: If successful, nebulized amikacin could enhance lung drug delivery and reduce treatment failure or recurrence of gram-negative pneumonia in VA-ECMO patients.

How similar studies have gone: Previous data on inhaled antibiotics in ECMO patients are limited; this approach is exploratory with potential for meaningful improvement if pharmacokinetic benefits are realized.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient 18 years or older
2. Circulatory assistance by veno-arterial ECMO for at least 24 hours prior to documentation of pneumonia
3. Invasive mechanical ventilation
4. Diagnostic suspicion of pneumonia based on evocative criteria (presence of at least 2 of the following criteria): fever (superior to 38. 5°C), hypothermia (inferior to 36.0°C), hyperleukocytosis (superior to 11 × 10\^9 l-1) or leukopenia (inferior to 4 × 10\^9 l-1), purulent tracheobronchial secretions, altered oxygenation with need to increase FiO2 on ECMO or ventilator for the same SaO2 or PaO2 target, new or persistent pulmonary infiltrate(s) on chest x-ray in bed, or image suggestive of pneumonia on chest CT, or consolidation of appearance suggestive of an infectious origin on pulmonary ultrasound.
5. And microbiological confirmation of Gram-negative ventilator-associated pneumonia by quantitative culture on bronchoalveolar lavage (BAL, significance threshold superior to 10\^4 CFU/ml) or protected distal sampling (PDP, significance threshold superior to 10\^3 CFU/ml).
6. Probabilistic antibiotic therapy with piperacillin - tazobactam
7. Informed consent obtained from the patient or trusted support person if unable to consent at the time of inclusion, or inclusion procedure in emergency situations.
8. Patient affiliated to social security (excluding AME)

Exclusion Criteria:

1. Known allergy to amikacin or another aminoglycoside or to an auxiliary drug or to any of their excipients.
2. Contraindication to the administration of amikacin or its excipients listed in the summary of product characteristics.
3. Contraindication to the administration of an auxiliary drug or to one of its excipients listed in the summary of product characteristics.
4. Contraindications to nebulization
5. Intravenous antibiotic therapy started more than 72 hours before randomization
6. Probabilistic venous antibiotic therapy other than piperacillin - tazobactam
7. Administration of inhaled antibiotics within 7 days prior to inclusion
8. Positive pregnancy test for women of childbearing potential
9. Presence of HIV infection with CD4 count inferior to 200 cells/mm3 or fungal lung infection or pulmonary abscess or empyema
10. Presence of renal insufficiency with creatinine clearance inferior to 15 ml/min, with the exception of patients receiving continuous renal purification or daily hemodialysis sessions as part of their intensive care unit management.
11. Patent moribund (SAPS II superior to 75) or high probability of death within 48 hours
12. Patient under legal protection (curatorship, guardianship or safeguard of justice)
13. Participating in another interventional clinical trial or within the exclusion period at the end of a previous study.

Where it's running

  • Hôpital Pitié-Salpêtrière
    Paris, France     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.